If your research involves human subjects, refer to the following guidance to assist you with writing Element 5: Access, Distribution, or Reuse Considerations.

NIH Guidance

Review NOT-OD-22-213 Supplemental Information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data. See sections on "Best Practices for Protecting Participant Privacy When Sharing Scientific Data" and "Points to Consider for Choosing Whether to Designate Scientific Data for Controlled Access"

Review NOT-OD-22-214 Supplemental Information to the NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/Alaska Native Participant Data. See sections on "Considerations for Researchers Working with Tribal Nations" and "Best Practices for Researchers".

Also consult the NIH's Informed Consent for Secondary Research with Data and Biospecimens: Points to Consider and Sample Language for Future Use and/or Sharing. This document addresses consent for the storage and sharing of data and biospecimens collected during primary research, for the purposes of future secondary research. 

See the sharing.nih.gov Frequently Asked Questions about limiting sharing of data

UVA Resources

Sharing Data Outside UVA - Guidance and Assistance

• Sharing Patient Data for Research: UVA Health Privacy Office Guidance (iTHRIV Portal) (UVA only)
• Certifying UVA Research Datasets When Sending Outside of UVA (iTHRIV Portal) (UVA only)
  • Contact Research & Clinical Trial Analytics to certify that your data has been properly deidentified

De-identification - Guidance

• HHS Guidance: De-identification of PHI in accordance with HIPAA (iTHRIV Portal)
• HIPAA Patient Identifiers (iTHRIV Portal)

NIH issued the Data Management and Sharing (DMS) policy (effective January 25, 2023) to promote the sharing of scientific data. Read more at sharing.nih.gov, but in short, under the DMS policy, NIH expects that investigators and institutions:

• Plan and budget for the managing and sharing of data
• Submit a DMS plan for review when applying for funding
• Comply with the approved DMS plan

To have a librarian review your DMS plan, please complete this request form.